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Incident severe thrombocytopenia in veterans treated with pegylated interferon plus ribavirin for chronic hepatitis C infection

Authors

  • John A. Hermos,

    Corresponding author
    1. VA Cooperative Studies Program, Massachusetts Veterans Epidemiology Research and Information Center (MAVERIC), VA Boston Healthcare System, Boston, MA, USA
    2. Department of Medicine, Boston University School of Medicine, Boston, MA, USA
    • Correspondence to: J. A. Hermos, VA Boston Healthcare System (151MAV) 150S. Huntington Ave, Boston, MA 02130, USA. E-mail: jhermos@bu.edu

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  • Lien Quach,

    1. VA Cooperative Studies Program, Massachusetts Veterans Epidemiology Research and Information Center (MAVERIC), VA Boston Healthcare System, Boston, MA, USA
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  • David R. Gagnon,

    1. VA Cooperative Studies Program, Massachusetts Veterans Epidemiology Research and Information Center (MAVERIC), VA Boston Healthcare System, Boston, MA, USA
    2. Department of Biostatistics, Boston University School of Public Health, Boston, MA, USA
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  • H. Christian Weber,

    1. Department of Medicine, Boston University School of Medicine, Boston, MA, USA
    2. Gastroenterology Section, VA Boston Healthcare System, Boston, MA, USA
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  • Arman Altincatal,

    1. VA Cooperative Studies Program, Massachusetts Veterans Epidemiology Research and Information Center (MAVERIC), VA Boston Healthcare System, Boston, MA, USA
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  • Kelly Cho,

    1. VA Cooperative Studies Program, Massachusetts Veterans Epidemiology Research and Information Center (MAVERIC), VA Boston Healthcare System, Boston, MA, USA
    2. Department of Medicine, Harvard Medical School, Boston, MA, USA
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  • Elizabeth V. Lawler,

    1. VA Cooperative Studies Program, Massachusetts Veterans Epidemiology Research and Information Center (MAVERIC), VA Boston Healthcare System, Boston, MA, USA
    2. Department of Medicine, Harvard Medical School, Boston, MA, USA
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  • Kelly M. Grotzinger

    1. GlaxoSmithKline, Collegeville, PA, USA
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ABSTRACT

Purpose

We sought to determine the incidence and risks for severe thrombocytopenia (platelets < 50 000/μL) in United States Veteran patients treated with pegylated interferon (PEG-IFN) plus ribavirin for hepatitis C virus-positive (HCV) chronic liver disease (CLD).

Methods

Using a retrospective, observational cohort study design to analyze databases from the New England Veterans Healthcare System, we identified 979 patients diagnosed with HCV-positive CLD treated solely with PEG-IFN plus ribavirin. The cohort was stratified by pre-treatment platelet counts of 50 000–100 000/μL (N = 90), >100 000–150 000/μL (N = 162), and >150000μL (N = 727). The cumulative incidence of severe thrombocytopenia and major bleeding events were determined for each baseline platelet group for 48 weeks following treatment initiation. Multivariable Cox regression was used to identify risk factors for incident severe thrombocytopenia.

Results

Overall, severe thrombocytopenia occurred in 6.1% (N = 60), but in 41.1% of patients with pre-treatment platelet counts 50 000–100 000/μL compared with 11.7% (p < 0.001) and 0.55% (p < 0.001) in the two higher pre-treatment platelet groups. Most episodes occurred within the first 12 weeks of treatment. Median nadir count for these 60 patients was 35 000/μL (inter-quartile range 28 000, 44 000). Baseline platelet counts of 50 000–100 000/μL [adjusted hazard ratio (HR) = 3.81; 95%CI = 2.07–7.00] and hemoglobin <10 g/dL (adjusted HR = 3.39; 95%CI = 1.45–7.960) associated with severe thrombocytopenia. Major bleeding events during the 48-week observation period were rare (N = 5, 0.51%).

Conclusions

The incidence of severe thrombocytopenia in a large, observational cohort of veteran patients with HCV CLD treated with PEG-IFN plus ribavirin was 6.1%. Low pre-treatment platelet counts and hemoglobin levels associated with early, incident severe thrombocytopenia. Copyright © 2014 John Wiley & Sons, Ltd.

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